BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 15014074 · Received July 14, 2022

    Report

    Report Number
    3011393376-2022-02077
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 25, 2022
    Report Date
    September 16, 2022
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 0

    CORRECTION - SECTION E INITIAL REPORTER ADDRESS INFORMATION WAS UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL (UNKNOWN REASON FOR HOSPITALIZATION) AND BLOOD GLUCOSE RESULTS WERE TAKEN FROM THE PATIENT´S ACCU-CHEK GUIDE BLOOD GLUCOSE METER AND COMPARED WITH A LAB RESULT. (B)(6) 2022 08:48 AM ACCU-CHEK GUIDE (SYSTEM 1): LO (RESULT LESS THAN 20 MG/DL) (B)(6) 2022 08:50 AM ACCU-CHEK GUIDE (SYSTEM 1): LO (RESULT LESS THAN 20 MG/DL) LAB RESULT WITHIN 15 MINUTES: 130 MG/DL THERE WAS NO TREATMENT DECISION BASED ON THE ACCU-CHEK GUIDE READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451726 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 102832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AMOXICILLIN| ASPIRIN| ATENOLOL| BETAHISTINE HCL| DIMENHYDRINATE| DOMPERIDONE| FLUNARIZIN| ISOSORBIDE| LOSARTAN POTASSIUM| METFORMIN| METOCLOPRAMIDE| MTV MULTIVITAMINS| PARACETAMOL| SIMVASTATIN| VITAMIN B COMPLEX